Rectal NeoplasmsPhase 2NCT01613469
Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
A Phase 2 study testing 5FU/Leucovorin in people with Rectal Neoplasms, run by Marks, John, M.D. at 1 site in United States.
Trial summary
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- 5FU/Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 16 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
- clinical/radiological stages T2,T3,or T4, N0-1
- ANC >1500, PLT>100,000
- AST and alkaline phosphatase < 2.5 X ULN
- bilirubin < 1.5 X ULN
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- CrCl > 50 ml/min using Cockcroft-Gault formula
- KPS >60
- ECOG Performance Scale 0-2
- No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
- no evidence of metastatic disease
Who cannot join
- initial tumor fixation to pelvic bone or side wide; technically unresectable disease
- any evidence of distant metastasis
- perforation
- obstruction
- hereditary non-polyposis colorectal cancer
- synchronous primary colon carcinomas except T1 lesions
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- known dihydropyrimidine dehydrogenase deficiency
- prior radiation therapy to the pelvis
- prior chemotherapy for malignancies
- known existing uncontrolled coagulopathy
- pregnancy or lactation
- women of childbearing potential not using reliable and appropriate contraceptive method
- serious, uncontrolled concurrent infection(s)
- participation in any investigational drug study within 4 weeks preceding the start of study treatment
- clinically significant heart disease
- other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)
- major surgery within 4 weeks prior to the study treatment
- lack of physical integrity of the upper GI tract or malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.
Read the detailed description
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.
- Conditions
- Rectal Neoplasms
- Being tested
- 5FU/Leucovorin
- Keywords
- fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5FU/LeucovorinDrug
Also called SOC intervention
450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation.
| Study group | Role | What they receive |
|---|---|---|
| 5FU/Leucovorin- post distal rectal srgy | Other | Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer Receives: Drug: 5FU/Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
Measured: One year from the time of chemoradiation
Secondary outcomes (1)
The proportion of subjects with complete pathological response at surgical resection
At surgical intervention for incomplete clinical response or recurrence, complete pathological response is no evidence of residual disease at pathological examination of the resected specimen.
Measured: One year from chemoradiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startAug 2011
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Why it stopped: Re-eval of patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marks, John, M.D.
- Responsible party
- Sponsor
- Investigators
- John Marks, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613469
- Sponsor's protocol ID
- R12-3092L
- Status last verified
- Aug 2018
- First submitted
- 5 Jun 2012
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Habr-Gama A, Perez RO, Kiss DR, Rawet V, Scanavini A, Santinho PM, Nadalin W. Preoperative chemoradiation therapy for low rectal cancer. Impact on downstaging and sphincter-saving operations. Hepatogastroenterology. 2004 Nov-Dec;51(60):1703-7.
PubMed 15532809Habr-Gama A, de Souza PM, Ribeiro U Jr, Nadalin W, Gansl R, Sousa AH Jr, Campos FG, Gama-Rodrigues J. Low rectal cancer: impact of radiation and chemotherapy on surgical treatment. Dis Colon Rectum. 1998 Sep;41(9):1087-96. doi: 10.1007/BF02239429.
PubMed 9749491Habr-Gama A, Perez RO, Nadalin W, Nahas SC, Ribeiro U Jr, Silva E Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Long-term results of preoperative chemoradiation for distal rectal cancer correlation between final stage and survival. J Gastrointest Surg. 2005 Jan;9(1):90-9; discussion 99-101. doi: 10.1016/j.gassur.2004.10.010.
PubMed 15623449Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed.
PubMed 19934911Habr-Gama A, Perez RO. Non-operative management of rectal cancer after neoadjuvant chemoradiation. Br J Surg. 2009 Feb;96(2):125-7. doi: 10.1002/bjs.6470. No abstract available.
PubMed 19160360Petersen S, Hellmich G, von Mildenstein K, Porse G, Ludwig K. Is surgery-only the adequate treatment approach for T2N0 rectal cancer? J Surg Oncol. 2006 Apr 1;93(5):350-4. doi: 10.1002/jso.20452.
PubMed 16550556
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
- ClinicalTrials.gov ID
- NCT01613469
- Acronym / sponsor ID
- R12-3092L
- Conditions
- Rectal Neoplasms
- Keywords
- fluorouracil, leucovorin, radiotherapy, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Re-eval of patient population
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Marks, John, M.D.
- Study start
- Aug 2011
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.
Detailed description
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5FU/Leucovorin- post distal rectal srgy | Other | Drug: 5FU/LeucovorinAssess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- over 18 years old
- tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
- clinical/radiological stages T2,T3,or T4, N0-1
- ANC >1500, PLT>100,000
- AST and alkaline phosphatase < 2.5 X ULN
Key exclusion criteria (18 listed)
- initial tumor fixation to pelvic bone or side wide; technically unresectable disease
- any evidence of distant metastasis
- perforation
- obstruction
- hereditary non-polyposis colorectal cancer
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 |
|---|---|---|
| 5FU/LeucovorinAlso: SOC intervention450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation. | Drug | 5FU/Leucovorin- post distal rectal srgy |
Primary outcome
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
Time frame: One year from the time of chemoradiation
Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
1 secondary outcome
The proportion of subjects with complete pathological response at surgical resection
Time frame: One year from chemoradiation therapy
Results and safety
The study was stopped early (reason given: Re-eval of patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 15532809Habr-Gama A, Perez RO, Kiss DR, Rawet V, Scanavini A, Santinho PM, Nadalin W. Preoperative chemoradiation therapy for low rectal cancer. Impact on downstaging and sphincter-saving operations. Hepatogastroenterology. 2004 Nov-Dec;51(60):1703-7.
- Background: PubMed 9749491Habr-Gama A, de Souza PM, Ribeiro U Jr, Nadalin W, Gansl R, Sousa AH Jr, Campos FG, Gama-Rodrigues J. Low rectal cancer: impact of radiation and chemotherapy on surgical treatment. Dis Colon Rectum. 1998 Sep;41(9):1087-96. doi: 10.1007/BF02239429.
- Background: PubMed 15623449Habr-Gama A, Perez RO, Nadalin W, Nahas SC, Ribeiro U Jr, Silva E Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Long-term results of preoperative chemoradiation for distal rectal cancer correlation between final stage and survival. J Gastrointest Surg. 2005 Jan;9(1):90-9; discussion 99-101. doi: 10.1016/j.gassur.2004.10.010.
- Background: PubMed 19934911Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed.
- Background: PubMed 19160360Habr-Gama A, Perez RO. Non-operative management of rectal cancer after neoadjuvant chemoradiation. Br J Surg. 2009 Feb;96(2):125-7. doi: 10.1002/bjs.6470. No abstract available.
- Background: PubMed 16550556Petersen S, Hellmich G, von Mildenstein K, Porse G, Ludwig K. Is surgery-only the adequate treatment approach for T2N0 rectal cancer? J Surg Oncol. 2006 Apr 1;93(5):350-4. doi: 10.1002/jso.20452.
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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. This study is not recruiting at the moment.
John Marks, MD principal investigator
Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5FU/Leucovorin in people with Rectal Neoplasms, run by Marks, John, M.D. at 1 site in United States.
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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 16 Aug 2018. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Re-eval of patient population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer. (time frame: One year from the time of chemoradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613469, which also lists 6 linked publications.
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 16 Aug 2018.