Malignant Neoplasm of Anal CanalIMPACNCT06630793
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
A study testing IMPT (Intensity Modulated Proton Therapy) and IMRT (Intensity Modulated Radiation Therapy) in people with Malignant Neoplasm of Anal Canal, run by Tata Memorial Centre at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Neoplasm of Anal Canal
- What is being tested?
- IMPT (Intensity Modulated Proton Therapy) and IMRT (Intensity Modulated Radiation Therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 18 Mar 2025to 1 May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 80 years of age
- Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
- The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
- Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment.
- WHO or ECOG performance status 0-1
- HIV testing is known and HPV (P16) testing done on tissue sample.
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- With suitable blood test values for standard concurrent chemotherapy (Hb > 10 mg/dL, ANC > 1.5 cells/mm3, Platelets > 100,000 cells/mm3, Creatinine < 1.5 x ULN, Bilirubin < 3 x ULN, ALT < 3 x ULN) as deemed by a medical oncologist in team.
- The patient must be expected to tolerate the treatment and be compliant for follow up.
- No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc.
- Willing to consent to participate in the study.
Who cannot join
- Two or more synchronous primary cancers.
- When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process.
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- Poor reliability for follow-up and treatment completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Rahul Krishnatry, MD, +91-22-24177028 ext. 7028, krishnatry@gmail.com
Rahul Krishnatry, MD
About this study
Official title: Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
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).
Read more
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.
- Conditions
- Malignant Neoplasm of Anal Canal
- Being tested
- IMPT (Intensity Modulated Proton Therapy), IMRT (Intensity Modulated Radiation Therapy)
- Keywords
- IMPT, IMRT, Anal canal
- Medical subject headings
- Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: IMPT (Intensity Modulated Proton Therapy) |
| 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. Receives: Radiation: IMRT (Intensity Modulated Radiation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upto 6 months post-last cytotoxic therapy.
Secondary outcomes (8)
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.
Measured: 5 years since randomization
Regional Failure
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.
Measured: 5 years since randomization
Distant Relapse
The rate of relapse of the tumor outside the pelvic region.
Measured: 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.
Measured: 5 years since randomization
Disease-free Survival
The time from randomization to local or regional or distant recurrence of tumor or death
Measured: 5 years since randomization
Overall Survival
From randomisation till anal cancer or treatment-related death.
Measured: 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
Measured: 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)
Measured: 5 years since randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start18 Mar 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Anal CanalStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630793
- Sponsor's protocol ID
- 4336
- Acronym
- IMPAC
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
- ClinicalTrials.gov ID
- NCT06630793
- Acronym / sponsor ID
- IMPAC / 4336
- Conditions
- Malignant Neoplasm of Anal Canal
- Keywords
- IMPT, IMRT, Anal canal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical CTRT with IMPT (Intensity Modulated Proton Therapy) | Experimental | Radiation: IMPT (Intensity Modulated Proton Therapy)Patients randomized to proton therapy arm will receive radiotherapy with IMPT technique along with concurrent chemotherapy for a duration 6-8 weeks. |
| Radical CTRT with IMRT (Intensity Modulated Radiation Therapy) | Active comparator | Radiation: IMRT (Intensity Modulated Radiation Therapy)Patients randomized to photon arm will receive radiotherapy with IMRT technique along with concurrent chemotherapy for a duration 6-8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 and < 80 years of age
- Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
- The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
- Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment.
- WHO or ECOG performance status 0-1
Key exclusion criteria (4 listed)
- Two or more synchronous primary cancers.
- When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process.
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- Poor reliability for follow-up and treatment completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPT (Intensity Modulated Proton Therapy)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. | Radiation | Radical CTRT with IMPT (Intensity Modulated Proton Therapy) |
| IMRT (Intensity Modulated Radiation Therapy)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. | Radiation | Radical CTRT with IMRT (Intensity Modulated Radiation Therapy) |
Primary outcome
Grade 3 or higher acute toxicity
Time frame: Upto 6 months post-last cytotoxic therapy.
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.
8 secondary outcomes
Local Failure
Time frame: 5 years since randomization
Regional Failure
Time frame: 5 years since randomization
Distant Relapse
Time frame: 5 years since randomization
Colostomy-free Survival
Time frame: 5 years since randomization
Disease-free Survival
Time frame: 5 years since randomization
Overall Survival
Time frame: 5 years since randomization
Treatment-related late toxicities
Time frame: 5 years since randomization
Patient-Reported Health-Related Quality of Life QLQ-C30 questionnaires
Time frame: 5 years since randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPT (Intensity Modulated Proton Therapy) and IMRT (Intensity Modulated Radiation Therapy) in people with Malignant Neoplasm of Anal Canal, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Rahul Krishanatry, MD (02224177028 ext. 7028, krishnatry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or higher acute toxicity (time frame: Upto 6 months post-last cytotoxic therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.