Colorectal CancerPhase 2NCT00021398
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
A Phase 2 study testing fluorouracil, leucovorin calcium and conventional surgery in people with Colorectal Cancer, run by Fox Chase Cancer Center at 17 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fluorouracil, leucovorin calcium and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 1996to Sep 2018
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- Tumor extending through bowel wall (T3) OR
- Fixation to surrounding structures (T4) OR
- Nodal involvement by endorectal ultrasound (N1-2)
- Tumor extending through bowel wall, but not fixed (T3) must be:
- At least 4 cm or at least 40% of bowel circumference OR
- Accompanied by nodal involvement
- Evidence of transmural penetration confirmed by 2 of the following:
- CT scan
- Pelvic MRI
- Transrectal ultrasound
- Physical exam
- Proximal extent of tumor must not extend higher than 12 cm above dentate line and must be below pelvic peritoneal reflexion or sacral promontory
- Regional lymph node involvement allowed
- No distant metastases by CT scan of abdomen and pelvis or chest x-ray
PATIENT CHARACTERISTICS:
- Age: Over 18
- Performance status: ECOG 0-1
- Life expectancy: At least 2 years
- Hematopoietic:
- Leukocyte count greater than 4,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 10 g/dL
- Hepatic:
- SGOT and SGPT less than 1.5 times normal
- Bilirubin less than 1.5 mg/dL
- Renal: Creatinine less than 1.8 mg/dL
- Other:
- Not pregnant or nursing
- Negative pregnancy test
- No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix
- No psychiatric condition that would preclude informed consent
- No other serious medical illness that would limit survival
PRIOR CONCURRENT THERAPY:
- Biologic therapy: Not specified
- Chemotherapy: No prior chemotherapy for rectal cancer
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy for rectal cancer
- Surgery: No prior surgery for rectal cancer, except diagnostic biopsy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
Kimball Medical Center
Lakewood, New Jersey, 08701
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
North Penn Hospital
Lansdale, Pennsylvania, 19446
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Riverview Medical Center
Red Bank, New Jersey, 07701
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
Southern Chester County Medical Center
West Grove, Pennsylvania, 19390
About this study
Official title: Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the local recurrence rate, disease-free survival, and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium. II. Determine the toxicity rate in patients treated with this regimen. III. Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen. IV. Determine the quality of life of patients treated with this regimen. V. Determine if toxicity due to treatment, daily stool frequency, sexual dysfunction, and disease-free survival correlates with quality of life parameters in patients treated with this regimen. VI. Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen. VII. Determine post-chemoradiotherapy pathological response, margin status, and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen.
OUTLINE: Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days. Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40. Patients undergo surgical resection 4-6 weeks after completion of radiotherapy. At 4 weeks after surgery, patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week. Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the completion of pelvic and boost radiotherapy, at 4 weeks after completion of chemoradiotherapy (prior to surgery), and then at 3, 6, and 12 months after completion of study therapy. Patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 23-41 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- fluorouracil, leucovorin calcium, conventional surgery, radiation therapy
- Keywords
- stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy, Chemotherapy and Surgery | Experimental | Not described Receives: Drug: fluorouracil; Drug: leucovorin calcium; Procedure: conventional surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of toxicity
Measured: weekly during treatment
tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy
Measured: during radiation therapy and chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2004 (estimated)
- Study startJul 1996
- Primary completionJul 2001
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021398
- Sponsor's protocol ID
- CDR0000068776
- Other IDs
- P30CA006927, FCCC-96071, NCI-G01-1988
- Status last verified
- Jun 2020
- First submitted
- 11 Jul 2001
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00021398
- Acronym / sponsor ID
- CDR0000068776
- Conditions
- Colorectal Cancer
- Keywords
- stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1996
- Primary completion
- Jul 2001 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 13 Apr 2004 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.
Detailed description
OBJECTIVES: I. Determine the local recurrence rate, disease-free survival, and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium. II. Determine the toxicity rate in patients treated with this regimen. III. Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen. IV. Determine the quality of life of patients treated with this regimen. V. Determine if toxicity due to treatment, daily stool frequency, sexual dysfunction, and disease-free survival correlates with quality of life parameters in patients treated with this regimen. VI. Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen. VII. Determine post-chemoradiotherapy pathological response, margin status, and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen.
OUTLINE: Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days. Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40. Patients undergo surgical resection 4-6 weeks after completion of radiotherapy. At 4 weeks after surgery, patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week. Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the completion of pelvic and boost radiotherapy, at 4 weeks after completion of chemoradiotherapy (prior to surgery), and then at 3, 6, and 12 months after completion of study therapy. Patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 23-41 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy, Chemotherapy and Surgery | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Procedure: conventional surgery, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fluorouracil | Drug | Radiation Therapy, Chemotherapy and Surgery |
| leucovorin calcium | Drug | Radiation Therapy, Chemotherapy and Surgery |
| conventional surgery | Procedure or surgery | Radiation Therapy, Chemotherapy and Surgery |
| radiation therapy | Radiation | Radiation Therapy, Chemotherapy and Surgery |
Primary outcome
Frequency of toxicity
Time frame: weekly during treatment
tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy
Time frame: during radiation therapy and chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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.
Joshua Meyer, MD principal investigator
Fox Chase Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, leucovorin calcium and conventional surgery in people with Colorectal Cancer, run by Fox Chase Cancer Center at 17 sites 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?
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: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of toxicity (time frame: weekly during treatment). The study lists 2 primary outcomes in all. 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 5 Jun 2020.