Rectal Cancer, RadiotherapyPhase 2NCT02941562
A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
A Phase 2 study testing Short-course radiotherapy, FOLFOX4 chemotherapy,preoperative and Radiotherapy of neo-adjuvant therapy in people with Rectal Cancer, Radiotherapy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer, Radiotherapy
- What is being tested?
- Short-course radiotherapy, FOLFOX4 chemotherapy,preoperative and Radiotherapy of neo-adjuvant therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Consent to this study
- 2. Histological or cytological confirmed diagnostic of rectal carcinoma
- 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
- 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
- 5.With no presence of other organ metastasis or extra-regional lymph node involvement
- 6.With no history of chemotherapy
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- 7.ECOG score is 0 or 1
- 8.Adequate ability of bone marrow, liver and kidney function
- 9.No pregnancy
Who cannot join
- Unable to intake oral medicine
- Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
- HIV infection or Active chronic HBV or HCV
- Severe clinical infection at active stage
- Epileptic seizure need treatment
- History of organ transplantation
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- Renal failure or intaking renal dialysis
- Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
- Severe unhealed wound or skin ulcer or bone fraction
- Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years
- 12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
Trial locations and contacts
No sites are listed yet.
About this study
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
Read the detailed description
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
- Conditions
- Rectal Cancer, Radiotherapy
- Being tested
- Short-course radiotherapy, FOLFOX4 chemotherapy,preoperative, Radiotherapy of neo-adjuvant therapy, Concurrent chemotherapy of neo-adjuvant therapy, Radical rectal cancer resection
- Keywords
- rectal cancer, radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
FOLFOX4 chemotherapy,preoperativeDrug
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
Repeat every 2 weeks
Radiotherapy of neo-adjuvant therapyRadiation
Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
Concurrent chemotherapy of neo-adjuvant therapyDrug
Capecitabine 825mg/m2 twice daily 5 days/week
Radical rectal cancer resectionProcedure or surgery
Radical rectal cancer resection
FOLFOX4 chemotherapy,post-operativeDrug
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
Repeat every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chemotherapy with short-course radiotherapy | Experimental | Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy Receives: Radiation: Short-course radiotherapy; Drug: FOLFOX4 chemotherapy,preoperative; Procedure: Radical rectal cancer resection; Drug: FOLFOX4 chemotherapy,post-operative |
| Preoperative neo-adjuvant therapy | Active comparator | Preoperative treatment:neo-adjuvant therapy Receives: Radiation: Radiotherapy of neo-adjuvant therapy; Drug: Concurrent chemotherapy of neo-adjuvant therapy; Procedure: Radical rectal cancer resection; Drug: FOLFOX4 chemotherapy,post-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response
Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
Measured: Surgery
Secondary outcomes (2)
3-year Disease-Free Survival
time from radical resection to recurrence or end of follow-up
Measured: 3 years
3-year Overall Survival
time from radical resection to cancer caused death or end of follow-up
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer, RadiotherapyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Cui, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941562
- Sponsor's protocol ID
- XHGC-004
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
- ClinicalTrials.gov ID
- NCT02941562
- Acronym / sponsor ID
- XHGC-004
- Conditions
- Rectal Cancer, Radiotherapy
- Keywords
- rectal cancer, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 21 Oct 2016 (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.
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
Detailed description
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative chemotherapy with short-course radiotherapy | Experimental | Radiation: Short-course radiotherapy, Drug: FOLFOX4 chemotherapy,preoperative, Procedure: Radical rectal cancer resection, Drug: FOLFOX4 chemotherapy,post-operativePreoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy |
| Preoperative neo-adjuvant therapy | Active comparator | Radiation: Radiotherapy of neo-adjuvant therapy, Drug: Concurrent chemotherapy of neo-adjuvant therapy, Procedure: Radical rectal cancer resection, Drug: FOLFOX4 chemotherapy,post-operativePreoperative treatment:neo-adjuvant therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Consent to this study
- 2. Histological or cytological confirmed diagnostic of rectal carcinoma
- 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
- 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
- 5.With no presence of other organ metastasis or extra-regional lymph node involvement
Key exclusion criteria (11 listed)
- Unable to intake oral medicine
- Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
- HIV infection or Active chronic HBV or HCV
- Severe clinical infection at active stage
- Epileptic seizure need treatment
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 |
|---|---|---|
| Short-course radiotherapyPreoperative Radiation doses: 25 Gy in 5 fractions to the pelvis | Radiation | Preoperative chemotherapy with short-course radiotherapy |
| FOLFOX4 chemotherapy,preoperativeFOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks | Drug | Preoperative chemotherapy with short-course radiotherapy |
| Radiotherapy of neo-adjuvant therapyPreoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis | Radiation | Preoperative neo-adjuvant therapy |
| Concurrent chemotherapy of neo-adjuvant therapyCapecitabine 825mg/m2 twice daily 5 days/week | Drug | Preoperative neo-adjuvant therapy |
| Radical rectal cancer resectionRadical rectal cancer resection | Procedure or surgery | Preoperative chemotherapy with short-course radiotherapy, Preoperative neo-adjuvant therapy |
| FOLFOX4 chemotherapy,post-operativeFOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks | Drug | Preoperative chemotherapy with short-course radiotherapy, Preoperative neo-adjuvant therapy |
Primary outcome
Pathological Response
Time frame: Surgery
Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
2 secondary outcomes
3-year Disease-Free Survival
Time frame: 3 years
3-year Overall Survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short-course radiotherapy, FOLFOX4 chemotherapy,preoperative and Radiotherapy of neo-adjuvant therapy in people with Rectal Cancer, Radiotherapy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long Cui, MD.PhD. (+86-25077850, longcuidr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Response (time frame: Surgery). 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 24 Oct 2016.