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The standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy. It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge.
These side-effects include gastrointestinal (diarrhea, altered bowel habits, weight loss, bleeding, obstruction), genitourinary (difficulties in passing urine, passing blood in urine, difficulty in holding urine) and hematologic toxicities (anemia, low platelet count and increased predisposition to infections).
Proton therapy (IMPT) is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose. It is believed that these physical properties of proton therapy may help reduce the side effects of treatment.
Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities. In this study, there is a 66.7% chance that the patient will get IMPT based treatment, which may be able to reduce the toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical CTRT with IMPT (Intensity Modulated Proton Therapy) | Experimental | Patients randomized to proton therapy arm will receive radiotherapy with IMPT technique along with concurrent chemotherapy for a duration 6-8 weeks. |
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| Radical CTRT with IMRT (Intensity Modulated Radiation Therapy) | Active Comparator | Patients randomized to photon arm will receive radiotherapy with IMRT technique along with concurrent chemotherapy for a duration 6-8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPT (Intensity Modulated Proton Therapy) | Radiation | Proton therapy is a form of radiation treatment in which high doses can be delivered within the tumour while relatively sparing the surrounding normal tissues. This may help further reduce the side-effects of radiation treatment observed with IMRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or higher acute toxicity | The highest GI/GU/Hematological toxicity will be captured per patient will be documented using CTCAE v5.0 and the percentage of patients with more than Grade 3 toxicity will be added in each arm and compared proportionately. | Upto 6 months post-last cytotoxic therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Failure | Local control will be computed as the time between randomization and local relapse or progression, Measurable persistent disease after six months from the completion of chemoradiation therapy will be considered a local failure. | 5 years since randomization |
| Regional Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Rahul Krishanatry, MD | Contact | 02224177028 | 7028 | krishnatry@gmail.com |
| Dr Rahul Krishanatry, MD | Contact | 02224177028 | 7028 | krishanatry@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Centre | Recruiting | Mumbai | Maharashtra | 400012 | India |
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| ID | Term |
|---|---|
| C563020 | Anal Canal Carcinoma |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| IMRT (Intensity Modulated Radiation Therapy) | Radiation | The standard management of carcinoma of the anal canal is radiotherapy using the IMRT technique along with concurrent chemotherapy. The use of IMRT has reduced the treatment-related side-effects as compared to older radiation techniques. However, further reducing these side effects poses a major challenge. |
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From randomisation till a situation in which a patient who initially had no signs of disease in the pelvic and groin nodes later displays disease in these nodes after receiving treatment or reappearance of the disease in these nodes after they were initially cleared or the presence of persistent nodal disease for more than six months after completing the treatment. |
| 5 years since randomization |
| Distant Relapse | The rate of relapse of the tumor outside the pelvic region. | 5 years since randomization |
| Colostomy-free Survival | From the the time of randomization till the necessity for colostomy is clinically warranted or death due to any cause. | 5 years since randomization |
| Disease-free Survival | The time from randomization to local or regional or distant recurrence of tumor or death | 5 years since randomization |
| Overall Survival | From randomisation till anal cancer or treatment-related death. | 5 years since randomization |
| Treatment-related late toxicities | After 3 months of treatment and up to 5 years or death due to any cause, will be documented using CTCAE v5.0 | 5 years since randomization |
| Patient-Reported Health-Related Quality of Life QLQ-C30 questionnaires | Will be assessed using Health Related Quality of Life questionnaires (QLQ) of European Organization for Research and Treatment of Cancer (EORTC) | 5 years since randomization |