Locally Advanced Rectal CancerNCT02964468
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer
A study testing 3DCRT treatment (sequential boost) and Dose Escalation Intensity Modulated Radiotherapy treatment in people with Locally Advanced Rectal Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 9 sites in Spain.
Trial summary
The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- 3DCRT treatment (sequential boost) and Dose Escalation Intensity Modulated Radiotherapy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 9 sitesSpain
- Study dates
- Sep 2016to May 2020
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of adenocarcinoma of the rectum
- Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
- Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge
- Adequate liver/renal and haematological function.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- Age ≥ 18 years
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- Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Haemoglobin ≥ 8.0 g/dl
- Serum creatinine within normal institutional limits
- Bilirubin within normal institutional limits
- AST and ALT < 2.5 x the IULN
- Patient must sign study specific informed consent prior to study entry
Who cannot join
- Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Any evidence of distant metastases (M1)
- A synchronous primary colon carcinoma
Trial locations and contacts
9 sites in 1 country.
Fernando López Campos, Investigator contact
9 sites in 1 country
Spain9 sites, 8 recruiting
- Recruiting
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón
Virginia Morillo, vmorill@gmail.com
- Active, not recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real
- Recruiting
Hospital General de Elche
Elche, Alicante
Sandra Miranda, mirandal81@hotmail.com
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada
MªVictoria De Torres Olambrada, mariavictoria.detorres@salud.madrid.org
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Fernando López Campos, flcampos@salud.madrid.org
Fernando López Campos
- Recruiting
Hospital Universitario La Paz
Madrid
Isabel Rodríguez, isabel.rodriguezr@salud.madrid.org
- Recruiting
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid
María Dolores De Las Peñas Cabrera, dolorescabrera@telefonica.net
- Recruiting
Hospital Universitario Santiago de Compostela
Santiago de Compostela, La Coruña
Paula Peleteiro, paula.peleteiro.higuero@sergas.es
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Ester Jordá Sorolla, estherjordasorolla@gmail.com
About this study
Official title: Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
Read the detailed description
The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- 3DCRT treatment (sequential boost), Dose Escalation Intensity Modulated Radiotherapy treatment
- Keywords
- Rectal Cancer, IMRT, Radiation Dose Escalation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DCRT treatment (sequential boost)Radiation
Radiotherapy:
3DCRT treatment (sequential boost) 25 fractions fraction 1,8Gy by administering a total dose of 45 Gy on tumor and lymph nodes and lymph node chains more pelvic margin determined according to protocol.
3 fractions fraction 1,8Gy by sequentially administering an additional dose of tumor and lymph nodes 5,4Gy on more margin.
Chemotherapy:
According to routine clinical practice of the participating centers.
Dose Escalation Intensity Modulated Radiotherapy treatmentRadiation
Radiotherapy:
IMRT treatment (concomitant boost technique) 25 fractions fraction 2,15Gy by administering a total dose of tumor and lymph nodes 53,75Gy on more margin. Simultaneously we will proceed to the irradiation of pelvic lymph node chains according to protocol, a division of 1,8Gy per session until a total dose of 45 Gy.
Chemotherapy:
According to routine clinical practice of the participating centers.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with IMRT Dose Escalation | Experimental | Dose Escalation Intensity Modulated Radiotherapy treatment Receives: Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment |
| Treatment with 3DCRT | Active comparator | 3DCRT treatment (sequential boost) Receives: Radiation: 3DCRT treatment (sequential boost) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Measured: Through study completion, an average of 2 years
Gastrointestinal toxicity
Gastrointestinal adverse events as assessed by CTCAE v4.0
Measured: Two years
Secondary outcomes (5)
Tumor regression grade
Pathologic evaluation of the surgical specimen
Measured: Through study completion, an average of two years
Disease free survival
Measured: Three years
Overall survival
Measured: Five years
Acute Toxicity
Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
Measured: Two years
Quality of Life during the treatment
Assessed by EORTC QLQC30-CR29 questionnaries
Measured: Three years after the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2019
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Campos, Grupo de Investigación Clínica en Oncología Radioterapia
- Investigators
- Fernando López Campos, Investigator, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964468
- Sponsor's protocol ID
- RTRC--001
- Status last verified
- Jun 2019
- First submitted
- 9 Nov 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02964468
- Acronym / sponsor ID
- RTRC--001
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Rectal Cancer, IMRT, Radiation Dose Escalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2019 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 16 Nov 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 aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
Detailed description
The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with IMRT Dose Escalation | Experimental | Radiation: Dose Escalation Intensity Modulated Radiotherapy treatmentDose Escalation Intensity Modulated Radiotherapy treatment |
| Treatment with 3DCRT | Active comparator | Radiation: 3DCRT treatment (sequential boost)3DCRT treatment (sequential boost) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically proven diagnosis of adenocarcinoma of the rectum
- Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
- Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge
- Adequate liver/renal and haematological function.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
Key exclusion criteria (4 listed)
- Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Any evidence of distant metastases (M1)
- A synchronous primary colon carcinoma
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 |
|---|---|---|
| 3DCRT treatment (sequential boost)Radiotherapy: 3DCRT treatment (sequential boost) 25 fractions fraction 1,8Gy by administering a total dose of 45 Gy on tumor and lymph nodes and lymph node chains more pelvic margin determined according to protocol. 3 fractions fraction 1,8Gy by sequentially administering an additional dose of tumor and lymph nodes 5,4Gy on more margin. Chemotherapy: According to routine clinical practice of the participating centers. | Radiation | Treatment with 3DCRT |
| Dose Escalation Intensity Modulated Radiotherapy treatmentRadiotherapy: IMRT treatment (concomitant boost technique) 25 fractions fraction 2,15Gy by administering a total dose of tumor and lymph nodes 53,75Gy on more margin. Simultaneously we will proceed to the irradiation of pelvic lymph node chains according to protocol, a division of 1,8Gy per session until a total dose of 45 Gy. Chemotherapy: According to routine clinical practice of the participating centers. | Radiation | Treatment with IMRT Dose Escalation |
Primary outcome
Pathologic complete response
Time frame: Through study completion, an average of 2 years
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Gastrointestinal toxicity
Time frame: Two years
Gastrointestinal adverse events as assessed by CTCAE v4.0
5 secondary outcomes
Tumor regression grade
Time frame: Through study completion, an average of two years
Disease free survival
Time frame: Three years
Overall survival
Time frame: Five years
Acute Toxicity
Time frame: Two years
Quality of Life during the treatment
Time frame: Three years after the study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- 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. This study is not recruiting at the moment.
Fernando López Campos, Investigator contact
Fernando López Campos, Investigator principal investigator
Hospital Universitario Ramon y Cajal
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3DCRT treatment (sequential boost) and Dose Escalation Intensity Modulated Radiotherapy treatment in people with Locally Advanced Rectal Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 9 sites in Spain.
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 14 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando López Campos, Investigator (flcampos@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: Through study completion, an average of 2 years). 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 26 Jun 2019.