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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00082167 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Elekta Limited | INDUSTRY |
This research is being done to compare the effectiveness of high dose endorectal brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine in the treatment of cancer of the lowest part of the bowel (rectum).
Locally advanced rectal carcinoma continues to be a major oncologic problem in the United States with approximately 40,000 new cases diagnosed in 2011. For stage II/III rectal carcinoma, adjuvant chemoradiation and total mesorectal excision (TME) represent the major treatment advances that have increased cure rates over the past 30 years.
In the setting of TME, a landmark phase III German trial of stage II/III rectal cancer patients established neoadjuvant 5FU-based chemoradiation (NCRT) as standard of care over the same regimen given post-operatively. The preoperative arm showed superior local control (6% vs. 13% p=0.006), a complete pathologic response of 8%, a higher rate of sphincter preservation and less grade 3 toxicity compared to post-operative treatment. However, disease-free and overall survival (76% versus 74%, respectively) were no different because of the high rate of distant metastasis occurring in over 1/3 of patients (5yr DM 36 vs 38%,p=0.84). Importantly, those attaining a pathologic complete response had a decreased rate of distant metastasis and improved disease-free survival. Drawbacks to the regimen include acute grade 3 or 4 toxicity in 27% of patients, low compliance rates with postoperative chemotherapy (27 - 50%), and an overall decline in anorectal function shown by long-term studies.
Given the excellent locoregional control reported in TME surgical series, several trials have investigated whether certain patients may be spared preoperative radiotherapy. Two large randomized trials by Dutch and British investigators showed that a short preoperative course of hypofractionated EBRT (25 Gy in 5 fractions) followed by TME surgery decreased locoregional recurrence by 2/3 as compared to patients treated with TME surgery alone. In the Dutch trial, patients with mid and distal rectal cancers were most likely to benefit from radiotherapy. In these patients, preoperative radiation was shown to decrease locoregional recurrence by 5-fold (10% to 2%); however, the hypofractionated preoperative EBRT regimen was associated with a significant increase in acute and chronic morbidity. Indeed, the Dutch study revealed that irradiated patients, when compared to surgery alone, had more perineal wound healing problems after abdominoperineal resection (29% vs. 19%), worsening deterioration of anal sphincter dysfunction, and more severe long-term effects related to sexual functioning both in males (p=0.004) and females (p<0.002). Additionally, colleagues have reported a consistent negative impact on bowel function in those patients undergoing sphincter preservation. In reviewing the long-term data of the Swedish short course preoperative EBRT rectal cancer trial, Birgisson also reported a higher incidence of secondary tumors (9.5%) in patients treated with preoperative radiation when compared to patients having surgery alone (4.3%).
Modern approaches to address the risk of distant metastasis and poor compliance with adjuvant systemic chemotherapy (following NCRT) have incorporated newer effective chemotherapy agents earlier in the treatment protocol. For example, oxaliplatin has been one of the most widely studied agents as a result of its proven efficacy when combined with 5-fluorouracil and leucovorin (FOLFOX) both in the metastatic and adjuvant settings for colon cancer. Initial phase II studies with the addition of oxaliplatin to standard 5-FU based NCRT appeared to show improved pathologic complete response rates compared to standard NCRT. However, two phase III trials clearly show that the addition of oxaliplatin during 5FU-based NCRT does not significantly improve pathologic complete response, locoregional control, distant metastasis or survival but does increase acute grade 3-4 toxicity by two to three-fold.
One approach to limit toxicity from external beam radiotherapy is the use of intensity modulated radiation therapy (IMRT). IMRT can limit radiation dose to normal rectum (above and below the tumor) and surrounding organs at risk (OARs) such as bladder and sexual organs. IMRT utilizes multiple beams of radiation to treat the rectal tumor plus a margin and limits dose to OARs. While IMRT decreases radiation dose to normal structures, it requires an additional 2-3 cm margin for microscopic extension (clinical treatment volume=CTV), set-up error, and rectal motion (planning treatment volume=PTV). Furthermore, IMRT still requires 5-6 weeks of radiation with concurrent chemotherapy, is substantially more expensive than conformal radiation, and is especially prohibitive in countries where access to technology necessary for IMRT is limited. Based on the preliminary results of RTOG 0822 and others, it still remains to be determined whether IMRT confers a statistically significant improvement in pCR, toxicity rates and QOL relative to standard NCRT.
A novel approach to limit radiation toxicity is the use of high dose rate endorectal brachytherapy (Endo-HDR). Endo-HDR involves the placement of a silicon multicatheter applicator within the rectum to deliver large doses to the rectal tumor and mesorectum with rapid dose fall off to the surrounding organs. An Iridium 192 high dose rate brachytherapy source attached to a wire is inserted into each catheter to deliver a high dose of radiation therapy the tumor. High dose rate brachytherapy has been well established in various malignancies (prostate, uterine, sarcoma, head and neck) to escalate radiation dose to the tumor over a short period of time while sparing normal tissue. Compared with NCRT and IMRT, Endo-HDR delivers treatment internally to the tumor without having to pass through surrounding normal tissue and organs. It requires smaller margins (CTV/PTV=~1 cm) on the tumor since the applicator is positioned under fiducial guidance over the tumor without need for a margin for organ motion allowing greater sparing of OARs. Furthermore, the area of the rectum exposed to high dose radiotherapy is surgically removed at the time of resection which further minimizes chronic toxicity. Important structures that may be spared include bone marrow, small bowel, bladder, the autonomic nerves, sexual organs, anal sphincter and skin. Considering that 1/3 of patients will develop metastases, limiting bone marrow toxicity may contribute to better compliance with systemic treatment and allow for a better treatment strategy to target systemic recurrence. Another distinct advantage of Endo-HDR is the shortened treatment time (1 versus 6 weeks). Endo-HDR therefore provides a major logistic advantage for patients who may benefit from neoadjuvant therapy but who are geographically distant from radiation centers, elderly, or medically infirmed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT and Capecitabine | Active Comparator | Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications Followed by:
Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection |
|
| Endo-HDR | Experimental | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo-HDR (if randomized to this arm) | Radiation | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pathologic Complete Response | Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines:
| Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Higher Adverse Events | Number of participants with grade 3 or higher adverse events will be listed by relationship. Grading is by CTCAE 4 guidelines. Relationship, as determined by PI, is unrelated/unlikely/possible/probable/definite. | Up to 60 months |
| Change in EORTC QLQ-C30 Global Health Status Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amol K Narang, M.D. | The SKCCC at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33607 | United States | ||
| Winship Cancer Institute, Emory University |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMRT and Capecitabine | Patients will receive IMRT along with capecitabine. Followed by:
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam. Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2020 |
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| capecitabine and IMRT (if randomized to this arm) | Drug | Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy |
|
|
| IMRT (intensity modulated radiation therapy) | Radiation | Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications |
|
| FOLFOX6 | Drug |
|
|
|
| Surgery | Procedure | After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam. Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
|
Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL. The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported. |
| baseline, preop, postop, and at follow ups Y1-5 |
| Time to Death | Assessing the difference time to death rates among study participants. | Up to 60 months |
| Time to Distant Metastases Free Survival | Compare distant metastasis for both Endo-HDR and CRT. | Up to 60 months |
| Time to Progression Free Survival | Compare progression free survival for both Endo-HDR and CRT. | Up to 60 months |
| Time to Local Disease Recurrence | Compare locoregional control for both Endo-HDR and CRT. | Up to 60 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| The SKCCC at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Beth Israel Hospital | New York | New York | 10003 | United States |
| FG001 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IMRT and Capecitabine | Patients will receive IMRT along with capecitabine. Followed by:
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam. Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
| BG001 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| met baseline enrollment requirements as per protocol | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Pathologic Complete Response | Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines:
| Posted | Count of Participants | Participants | Up to 60 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events | Number of participants with grade 3 or higher adverse events will be listed by relationship. Grading is by CTCAE 4 guidelines. Relationship, as determined by PI, is unrelated/unlikely/possible/probable/definite. | Posted | Count of Participants | Participants | Up to 60 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Change in EORTC QLQ-C30 Global Health Status Score | Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL. The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported. | 3 patients randomised to IMRT arm had at least 1 form completed. 5 patients randomised to the ENDO arm had at least 1 form completed. | Posted | Mean | Full Range | score on a scale | baseline, preop, postop, and at follow ups Y1-5 |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Death | Assessing the difference time to death rates among study participants. | No patients were deceased during the study period. | Posted | Up to 60 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Distant Metastases Free Survival | Compare distant metastasis for both Endo-HDR and CRT. | No patients had metastases during study period. | Posted | Up to 60 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression Free Survival | Compare progression free survival for both Endo-HDR and CRT. | No patients had progression during study period. | Posted | Up to 60 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Local Disease Recurrence | Compare locoregional control for both Endo-HDR and CRT. | No patients had locoregional recurrence during study period. | Posted | Up to 60 months |
|
60 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMRT and Capecitabine | Patients will receive IMRT along with capecitabine. Followed by:
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection: Endo-HDR: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 0 | 5 | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| sacral decubitis ulcer | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| pain (NOS) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| rectovaginal fistula | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANC elevated | Investigations | CTCAE (4.0) | Systematic Assessment | Grade not specified |
|
| alanine amino transferase increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| aspartate amino transferase increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| creatinine decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| GI hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| nocturia | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| pain (NOS) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| anorexia | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| atrial flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| GI hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| nocturia | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| pain (NOS) | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| rectal bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| rectal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
| weight loss | Investigations | CTCAE (4.0) | Systematic Assessment | Grade 2 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amol Narang, MD | SKCCC @ Johns Hopkins Medicine | 410-955-7390 | anarang2@jhmi.edu |
| Nov 3, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D050397 | Radiotherapy, Intensity-Modulated |
| C410216 | Folfox protocol |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| >=65 years |
|
| Male |
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| OG001 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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| OG001 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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| OG001 | Endo-HDR (Potentially Randomized to This Arm) | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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| OG001 | Endo-HDR (Potentially Randomized to This Arm) | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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| OG001 | Endo-HDR (Potentially Randomized to This Arm) | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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| OG001 | Endo-HDR (Potentially Randomized to This Arm) | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by:
Then: Surgical Resection Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: * Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. |
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